UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation and analysis of the side effect of intraocular lens using symulation software.
Title of the study (Brief title)	Evaluation and analysis of the side effect of intraocular lens using symulation software.
Region	Japan

Condition
Condition	cataract patient presbyopia patient
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the visual performance of intraocular lens.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The Quality of Vision (QoV) Questionnaire.Halo & Glare simulator.
Key secondary outcomes	visual acuity contrast aberration

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients undergoing implantation with intraocular lens
Key exclusion criteria	Patients found to have other ocular diseases
Target sample size	150

Research contact person
Name of lead principal investigator	Santaro Noguchi
Organization	Saneikai Tsukazaki Hospital
Division name	Department of Ophthalmology
Address	68-1 Waku Aboshi-ku Himeji HYOGO,JAPAN
TEL	0792728555
Email	s.noguchi@tsukazaki-eye.net

Public contact
Name of contact person	Santaro Noguchi
Organization	Saneikai Tsukazaki Hospital
Division name	Department of Ophthalmology
Address	68-1 Waku Aboshi-ku Himeji HYOGO,JAPAN
TEL	0792728555
Homepage URL
Email	s.noguchi@tsukazaki-eye.net

Sponsor
Institute	Saneikai Tsukazaki Hospital
Institute
Department

Funding Source
Organization	Saneikai Tsukazaki Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 27 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2017 Year 04 Month 26 Day
Anticipated trial start date	2017 Year 04 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	observation test

Management information
Registered date	2017 Year 04 Month 26 Day
Last modified on	2017 Year 04 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031114